FDA reviewers criticize Mela skin cancer device

WASHINGTON (Reuters) - U.S. health regulators said Mela Sciences Inc's experimental device to help diagnose deadly skin cancer could cause harm because of the potential for misdiagnosis.

FDA staff pointed to numerous problems with Mela's study of the device, called MelaFind, including a significant lack of data, and urged a new clinical trial. But analysts saw major stumbling blocks ahead and were doubtful the company had enough resources to conduct another study.

"The FDA review team has significant concerns this device has not been studied adequately for its current indications for use and therefore puts the health of the public at risk," the U.S. Food and Drug Administration said in documents released on Tuesday.

The documents were released ahead of an FDA advisory panel meeting Thursday to weigh whether to approve the device for use in detecting melanoma. While the FDA will make the final approval decision, it often follows the advice of its panelists.

MELA DISPUTES FDA'S VIEW

The company has already seen various delays, with the FDA asking for more data and later postponing the meeting of outside advisers now scheduled for Thursday.

In its own documents, Mela outlined 13 areas of disagreement with the FDA. The company has said its noninvasive computerized system can help physicians diagnose early melanoma when more information is needed in deciding whether a skin biopsy is necessary.

Mela said the FDA staff believes that "the fatal risk of missing melanomas (two of 127) is not worth the marginal benefit of a clinically meaningless reduction in biopsy ratio compared to dermatologists."

The company said this view was "completely without context."

Boenning & Scattergood analyst Greg Chodaczek said that while the device missed some melanoma cases, it still has significant benefits compared with dermatologists, who miss more.

"You are comparing the device with the best of the best dermatologists in the country ... who miss about 15 percent to 20 percent of the melanoma cases," he told Reuters.